Aflibercept Arm for Macular Edema

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Macular Edema+2 More
Iluvien 0.19 MG Drug Implant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether or not a new treatment for DME is better than the standard treatment. It will enroll patients who have not had any DME treatments for the past 12 months, and compare the new treatment to the standard treatment.

Eligible Conditions
  • Macular Edema
  • Diabetic Macular Edema (DME)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: At 18 months

At 18 months
Mean change from baseline in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and subscale scores
Proportion of subjects with 15, 10 and 5 letter (ETDRS) gains from baseline
Baseline to 18 months
Area under the curve (AUC) of Best Corrected Visual Acuity (BCVA)
Area under the curve (AUC) of Center Subfield Thickness (CST)
Mean change from baseline in Center Subfield Thickness (CST)
Safety Outcome Endpoints: The incidence and severity of treatment-related adverse events
The mean total number of supplemental aflibercept injections needed during the study

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Aflibercept Arm
1 of 2
ILUVIEN Arm
1 of 2
Active Control

300 Total Participants · 2 Treatment Groups

Primary Treatment: Aflibercept Arm · No Placebo Group · Phase 4

Aflibercept Arm
Drug
ActiveComparator Group · 1 Intervention: Aflibercept · Intervention Types: Drug
ILUVIEN ArmActiveComparator Group · 2 Interventions: Iluvien 0.19 MG Drug Implant, Aflibercept · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 18 months

Who is running the clinical trial?

Alimera SciencesLead Sponsor
10 Previous Clinical Trials
1,909 Total Patients Enrolled
8 Trials studying Macular Edema
1,886 Patients Enrolled for Macular Edema
Samer Kaba, MDStudy ChairAlimera Sciences, Inc.

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
BCVA of ≤80 ETDRS Letters and ≥35 ETDRS Letters in the study eye at Screening Visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.